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Phase I Trial of STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematological Malignancies and Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling
Hematological Malignancies, Leukemia, Lymphoma, Metastatic or Unresectable Solid Tumors

Thank you

Trial Information

Phase I Trial of STA-5312 Administered on Alternate Weekdays Every Two Weeks to Patients With Hematological Malignancies and Patients With Solid Tumors

Inclusion Criteria:

- Male and female patients 18 years or older with one of the following malignancies:

- Histologically or cytologically confirmed hematological malignancy (other than Acute
Myeloid Leukemia and Myelodysplastic Syndrome) and if treatment is medically
indicated, or,

- Histologically-confirmed non-hematological malignancy that is metastatic or
unresectable and for which no standard therapy is available.

- Patients with CLL, PLL, CML, CTCL, ATL, and Non-Hodgkin's Lymphoma may be entered if
they are refractory to or have relapsed following conventional chemotherapy regimens
such as alkylating agents (e.g. chlorambucil and cyclophosphamide), anthracycline
combinations [e.g. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)],
and/or purine analogues (e.g. fludarabine monophosphate and 2-CDA) and are not
currently being considered for re-treatment with conventional regimens

- Patients with CLL and other leukemic malignancies will be staged according to the
modified Rai staging criteria [low-risk, intermediate-risk and high risk]. All
patients in the high-risk group (Stage III and IV) are eligible. Intermediate risk
patients (Stage I and II) with one or more criteria of active disease (such as
progressive lymphocytosis, lymphadenopathy, and splenomegaly, weight loss > 10%
within 6 months, extreme fatigue, fever and/or night sweats without evidence of
infection, etc.) are also eligible

- ECOG Performance Status of 0-2

- Life expectancy of greater than 12 weeks.

- Patients must have acceptable organ and marrow function at screening and pre-dose
visits as defined below unless approved medically by the clinical investigator.

- Absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic
malignancies and ≥1,500 cells/ul for patients with solid tumors

- Platelets greater than 100,000/ul

- Hgb greater than 8.5 g/dL

- Total bilirubin must be <1.5 mg/dL or < 2X upper limit of normal

- AST (SGOT) < 2.5 times the upper limit of normal

- ALT (SGPT) < 2.5 times the upper limit of normal

- Adequate renal function (serum creatinine < 2.0 mg/dL or a calculated creatinine
clearance greater than 50 mL/min)

- Electrocardiogram without evidence of clinically significant conduction abnormalities
or active ischemia as determined by the investigator.

- NCI grade 0-1 left ventricular ejection fraction within 30 days of dosing.

- The effects of STA-5312 on the developing human fetus are unknown. Therefore, women
of childbearing potential (defined as women under 50 years of age or history of
amenorrhea for < 12 months prior to study entry) must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry and for the duration of study participation. Should a female patient
become pregnant or suspect she is pregnant while participating in this study, she
should inform the treating physician immediately.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Women who are pregnant or lactating.

- Patients who have had chemotherapy, radiotherapy (except palliative radiation
delivered to < 20% of bone marrow), immunotherapy, or corticosteroids ( > 10 mg/day
of prednisone or equivalent) within 4 weeks prior to entering the study or those who
have not recovered from adverse events due to agents administered more than 4 weeks

- The use of nitrosoureas or mitomycin C within 6 weeks prior to study entry.

- Patients with prior peripheral blood stem cell rescue or bone marrow transplantation.

- History of primary brain tumors or active brain metastases. (Patients with
previously treated brain metastases who are not receiving corticosteroids or
anticonvulsants may be considered for enrollment)

- History of stroke or other significant neurologic limitations within 6 months prior
to study enrollment

- Use of any investigational agents within 4 weeks of study enrollment.

- History of severe allergic reactions to excipients (e.g. Tween 80) or had
hypersensitivity reactions to other chemotherapeutic agents similar in structure to

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements, as determined by the investigator.

- History of active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe
medical illness or infection.

- Grade 2 or higher sensory or motor neuropathy at screening.

- Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

February 2004

Completion Date:

December 2004

Related Keywords:

  • Hematological Malignancies
  • Leukemia
  • Lymphoma
  • Metastatic or Unresectable Solid Tumors
  • Hematological Malignancies
  • Leukemia
  • Lymphoma
  • Metastatic
  • Unresectable solid tumors
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Hematologic Neoplasms



Newark Beth Israel Medical Center Newark, New Jersey  07112
Tufts New England Medical Center Boston, Massachusetts  02111
University of Chicago Chicago, Illinois  60637
The Sarah Cannon Cancer Center Nashville, Tennessee  37203
Carolinas HealthCare System Charlotte, North Carolina  
Wilshire Oncology Medical Group Glendora, California  91741
The West Clinic Memphis, Tennessee  38120
Baptist Cancer Institute Jacksonville, Florida  32207